NCT02610777 · OUTCOME
Six-month Survival Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- survival probability
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Month 6
What was measured
Kaplan-Meier estimate of probability of OS at the end of the month 6 from randomization.
Analysis population: ITT Population was defined as all participants who were randomized. Overall number analyzed are the number of participants with data available for analyses.
Groups in this outcome
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
| Group | Source count |
|---|---|
| Azacitidine 75 mg/m^2 | 50 |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 53 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Azacitidine 75 mg/m^2 | 0.806 | Not reported | 0.684 | 0.885 | Not reported |
| Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2 | 0.914 | Not reported | 0.805 | 0.963 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.684
- upper Limit
- 0.885
- value
- 0.806
- group Id
- OG001
- lower Limit
- 0.805
- upper Limit
- 0.963
- value
- 0.914
- denoms
- counts
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 53
- units
- Participants
- description
- Kaplan-Meier estimate of probability of OS at the end of the month 6 from randomization.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG000
- title
- Azacitidine 75 mg/m^2
- description
- Azacitidine 75 mg/m\^2, infusion, intravenously or subcutaneously, on Day 1 through Day 5, Days 8 and 9 and pevonedistat 20 mg/m\^2, infusion, intravenously, on Days 1, 3, and 5 in 28-day treatment cycles until unacceptable toxicity, relapse, transformation to AML (for participants with HR MDS or CMML), or progressive disease (for participants with low-blast AML).
- id
- OG001
- title
- Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2
- param Type
- NUMBER
- population Description
- ITT Population was defined as all participants who were randomized. Overall number analyzed are the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Month 6
- title
- Six-month Survival Rate
- type
- SECONDARY
- unit Of Measure
- survival probability
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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